YY/T 0681.14-2018 PDF in English
YY/T 0681.14-2018 (YY/T0681.14-2018, YYT 0681.14-2018, YYT0681.14-2018)
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Test methods for sterile medical device package. Part 14: Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air
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Standards related to (historical): YY/T 0681.14-2018
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YY/T 0681.14-2018: PDF in English (YYT 0681.14-2018) YY/T 0681.14-2018
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.040
C 31
Test methods for sterile medical device package - Part 14:
Testing the microbial barrier for porous packaging
materials under moist conditions and with passage of air
ISSUED ON: NOVEMBER 7, 2018
IMPLEMENTED ON: NOVEMBER 1, 2019
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Testing the microbial barrier for porous packaging materials under moist
conditions ... 6
4 Testing the microbial barrier for porous packaging materials with passage of
air ... 10
5 Precision and bias ... 15
Appendix A (Informative) Precision and bias ... 16
References ... 20
Test methods for sterile medical device package - Part 14:
Testing the microbial barrier for porous packaging
materials under moist conditions and with passage of air
1 Scope
This Part specifies the methods for testing the microbial barrier for porous
packaging materials under moist conditions and with passage of air.
The test methods given in this Part apply to the packaging materials for
terminally sterilized medical devices.
2 Normative references
The following documents are essential for the application of this document. For
dated references, only the dated editions apply to this document. For undated
references, the latest editions (including all amendments) apply to this
document.
GB/T 450-2008 Paper and board -- Sampling for testing and identification of
machine and cross direction, wire side and felt side
Pharmacopoeia of the People’s Republic of China (2015 Edition)
3 Testing the microbial barrier for porous packaging
materials under moist conditions
3.1 Method summary
ADD dropwise the microorganism droplets onto the test sample. After the
droplets are dried, an experiment is performed to determine whether
microorganisms have penetrated to the other side of the sample.
3.2 Sampling
TAKE samples in accordance with the GB/T 450-2008.
3.3 Sample preparation and quantity
The number of microorganisms in the microbial suspension used for the test
shall be 107 to 108 per milliliter.
3.6 Test implementation
3.6.1 General
PLACE test samples of each of the packaging material treated as 3.3 on a
sterilized substrate, e.g., in a Petri dish or on its lid. In actual use, the side that
may be subject to contamination is facing up.
If there is no indication of the contaminated surface of the packaging material,
both surfaces shall be tested with the same number of test samples.
TAKE 5 drops from the 1:100 dilution of broth series dilution (3.5), 0.1 mL per
drop. ADD dropwise to the upper surface of each test sample. Each drop shall
not be in contact with each other and should be equally spaced.
The droplets shall be allowed to dry completely under sterile conditions for 6 h
to 16 h. The temperature at this stage shall be maintained at (22 ± 3) °C.
Each sample should be placed on the surface of a blood agar plate (3.4.4) with
the inoculation surface facing up so that the entire test surface is in contact with
the agar (lightly smoothed with a coating bar). REMOVE the test samples after
5 s to 6 s. The plate should be cultured at 37 °C for 16 h to 24 h.
3.6.2 Positive spot check
In order to check the growth of the test microorganisms used, an additional test
sample of the packaging material treated as 3.3 is also inoculated and dried as
described in 3.6.1. The inoculation surface of the test sample is surface-
contacted with a blood agar plate as a positive check. After culture (3.6.1), the
test microorganisms on the plate shall grow significantly.
3.6.3 Negative spot check
As a negative check, an additional test sample parallel to the inoculated test
sample should be treated as described in 3.6.1, but not inoculated with the
microbial suspension. At the end of culture, there shall be no colony growth on
the blood agar plate.
3.7 Test evaluation
3.7.1 General
This test is designed as a “Conforming/Non-conforming” type test. Therefore,
the precision of the measured values is not reported in principle. If the positive
and negative checks of 3.6.2 and 3.6.3 are passed, the sensitivity of the method
conditioned for at least 24 h at an ambient temperature of (23 ± 1) °C and a
relative atmospheric humidity of (50 ± 2) %.
TEST the side of the packaging material that may be contaminated in actual
use. If both sides are tested, the number of test samples prepared should be
doubled. It also applies when the tester does not know which side the
contaminated surface is.
4.4 Appliances and consumables
4.4.1 General
All appliances and consumables in contact with the medium should be sterilized
in a steam sterilizer at 121 °C for 15 min.
4.4.2 Appliances
4.4.2.1 10 sets of microbial barrier test components, including:
— 1 thread mouth test bottle with a nominal volume of 250 mL; and
— 1 thread lid that can withstand sterilization and is covered with a 34 mm
diameter opening. It shall be ensured that the thread lid does not release
any substances that may affect the packaging material or
microorganisms in the test during the sterilization process.
4.4.2.2 20 seal rings with a diameter of 34 mm that can withstand sterilization,
made of polytetrafluoroethylene (PTFE) or with PTFE coating. These seal rings
do not release any substances that may affect the packaging material or
microorganisms in the test.
4.4.2.3 Steam sterilizer.
4.4.2.4 Refrigerator.
4.4.2.5 Incubator.
4.4.2.6 Aluminum foil.
4.4.2.7 Filter paper.
4.4.2.8 Laboratory thermometer.
4.4.2.9 Tools for shearing or punching samples.
4.4.2.10 Measuring cylinder.
4.5 Medium
POUR 20 mL of the medium prepared as 4.5 into each clean test bottle, and
COOL to solidify. The medium temperature shall be at least 50 °C during filling.
4.7.2 Loading test samples
Each test sample should be placed between two seal rings on the top of the
test bottle and then secured with a thread lid to hold the test sample and seal
rings tightly against the top of the test bottle. If the seal ring used has only one
coating, the coated surface shall face the test sample.
4.7.3 Sterilization
The microbial barrier test kit prepared in accordance with 4.7.1 and 4.7.2 should
be sterilized in a steam sterilizer at 121 °C for 20 min. The thread lid should be
covered with aluminum foil before sterilization.
4.7.4 Air flow generation
After sterilization and cooling of the microbial barrier test kits to room
temperature, each test sample is covered with 0.25 g of powdered quartz. In
order to avoid cross-contamination in the laboratory, filter paper should be used
to cover the thread lid.
Each microbial barrier test kit is then placed in an incubator and heated to (50
± 3) °C. Thereafter, the microbial barrier test kits are placed in a refrigerator
which is set to a temperature of (10 ± 3) °C. The process of heating to cooling
(from 50 °C to 10 °C) should be carried out a total of 5 times.
For ease of operation, it is recommended to measure the heating time and
cooling time before the start of the test. Each cycle should be no less than 40
min.
It is advisable not to shake the test kits as much as possible during the test.
4.7.5 Culture
The microbial barrier test kits are incubated at 37 °C for 24 h.
4.7.6 Test evaluation
This test is designed as a “Conforming/Non-conforming” type test. Therefore,
the precision of the measured values is not reported in principle. If the positive
and negative checks of 4.9 are passed, the sensitivity of the method is
sufficiently reliable.
After culture, the microbial barrier test kits should be removed from the
incubator. Colonies formed on the medium are counted.
Appendix A
(Informative)
Precision and bias
A.1 Overview
In 2013, the Sterile Barrier Association (SBA) conducted a laboratory synergy
test to evaluate the precision (repeatability and reproducibility) of the test
method.
A total of 5 German laboratories participated in the test, and one of the
laboratories was independently tested by two groups of testers. In this way, a
total of 6 sets of test data were obtained.
The test samples used in this test include various kinds of materials, including
materials that are expected to prevent microbial penetration, as well as
materials that are expected to penetrate microorganisms. There are 3 samples
for the microbial barrier test under moist conditions, numbered F1 to F3. There
are 4 samples for the microbial barrier test with passage of air, numbered L1 to
L4.
All samples are sterilized at 121 °C for 15 min. TEST separately according to
the test methods specified in the standard. The only deviation is that no
additional 20 test samples are taken for retesting in the microbial barrier test
under moist conditions.
A.2 Results
Since the test method is designed as a “Conforming/Non-conforming” type test,
the statistical total mean as well as the intra-laboratory and inter-laboratory
precision data are not practical and are only used to provide information.
The test samples are simultaneously judged as “Conforming/Non-conforming”.
If the number of colonies in a single plate or sample exceeds 100 CFU, 100
CFU is counted for the result evaluation.
Statistical evaluation is performed according to DIN ISO 5725-1ff.
Mandel’s h-statistics test is used for outlier testing.
Corresponding results of laboratories considered to be outliers do not
participate in statistical evaluation.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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